• 文章类型: Journal Article
    目的:这项研究的目的是评估使用具有特定温度-时间间隔的二极管激光器是否可以对骨整合植入物进行热植入物去除。
    方法:首先,在10头猪的上颌骨和下颌骨两侧进行了前三个前磨牙的拔牙。三个月后,将植入物插入10头猪的上下颚。再过三个月,骨整合植入物用激光设备加热至50°C的温度1分钟。14天后,植入物稳定性商(ISQ),扭矩输出值,使用共振频率分析评估骨与植入物接触(BIC)比率。
    结果:ISQ值显示各组内或对照组与试验组之间无显著差异。此外,扭矩输出和BIC值测量结果在两组之间无显著差异.
    结论:在50°C时,BIC值的变化明显较小;然而,这些差异并不显著。未来的研究应该以更高的温度或更长的时间间隔评估相同的程序。
    结论:仅在50°C下持续1分钟,牙种植体将无法预测地脱整合。
    OBJECTIVE: The aim of this study was to evaluate whether thermal implant removal of osseointegrated implants is possible using a diode laser with an specific temperature-time interval.
    METHODS: First, tooth extraction of the first three premolars was performed in the maxilla and mandible on both sides of 10 pig. After 3 months, implants were inserted into the upper and lower jaws of 10 pigs. After 3 more months, osseointegrated implants were heated with a laser device to a temperature of 50 °C for 1 min. After 14 days, the implant stability quotient (ISQ), torque-out values, and bone-to-implant contact (BIC) ratio were assessed using resonance frequency analysis.
    RESULTS: ISQ values showed no significant differences within each group or between the control and test groups. Furthermore, torque-out and BIC value measurements presented no significant differences between the groups.
    CONCLUSIONS: At 50°C, changes in the BIC values were noticeably smaller; however, these differences were not significant. Future studies should evaluate the same procedures at either a higher temperature or longer intervals.
    CONCLUSIONS: With only 50 °C for 1 min, a dental implant will not de-integrate predictably.
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  • 文章类型: Journal Article
    这项研究的目的是分析插入扭矩的影响,骨类型,以及种植体周围骨质流失对圆柱形外六角(EH)和莫尔斯锥(MT)种植体稳定性商(ISQ)的影响。在20名符合纳入和排除标准的患者的无牙区域放置了44个单个植入物。植入物放置后(t1)和骨整合后(下颌骨和上颌骨的四个月和六个月,分别)(t2),插入扭矩,共振频率,使用探测深度和数字根尖周X线摄影测量种植体周围骨丢失。对于EH和MT植入物,III型骨的t1和t2之间的ISQ值存在显着差异。当比较所有评估部位的EH或MT的骨类型时,未观察到骨丢失值的显着差异。根据射线照相术评估的边缘骨丢失,MT组和EH组之间无显著差别。对于MT(相关性:0.439;p=0.041)和EH(相关性:0.461;p=0.031)植入物,扭矩与ISQt1值之间呈正相关。对于EH和MT植入物,插入扭矩越大,ISQ值越大(中度正相关)。MT植入物的骨类型与ISQt1之间存在弱负相关。相反,EH植入物的骨类型与ISQt1之间未观察到相关性。在所有情况下,植入物周围的骨丢失在临床上是正常的.
    The objective of this study was to analyze the influence of insertion torque, bone type, and peri-implant bone loss on implant stability quotient (ISQ) of cylindrical external hexagon (EH) and Morse Taper (MT) implants. Forty-four single implants were placed in the edentulous areas of 20 patients who met the inclusion and exclusion criteria. Immediately after implant placement (t1) and after osseointegration (four and six months for mandible and maxilla, respectively) (t2), insertion torque, resonance frequency, and peri-implant bone loss were measured using probing depths and digital periapical radiography. A significant difference was noted in the ISQ values between t1 and t2 in type III bone for EH and MT implants. No significant difference in bone loss values was observed when comparing bone types for EH or MT in all evaluated sites. Based on marginal bone loss assessed using radiography, there was no significant difference between the MT and EH groups. A positive correlation between torque and ISQ t1 value was observed for MT (correlation: 0.439; p = 0.041) and EH (correlation: 0.461; p = 0.031) implants. For EH and MT implants, the greater the insertion torque, the greater was the ISQ value (moderately positive correlation). A weak negative correlation was found between bone type and ISQ t1 for MT implants. Contrarily, no correlation was observed between bone type and ISQ t1 for EH implants. In all cases, bone loss around the implants was clinically normal.
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  • 文章类型: Journal Article
    目的:影响牙种植成功率的最重要因素之一是边缘骨丢失。本研究的目的是探讨种植体的垂直位置和软组织厚度对牙种植体边缘骨丢失率的影响。
    方法:在这项单盲随机临床试验研究中,33例患者的下颌骨后部放置了56个植入物(19名女性,14名男性)分为两组。该组的crestal(28个植入物)和crestal下(28个植入物)植入物,每组分为软组织厚度为2mm且小于2mm(14个植入物)和大于2mm(14个植入物)的两个亚组.根据植入物垂直位置的影响,通过Scanora5.2程序使用X射线照片数字平行度测量边缘骨丢失量。软组织厚度,安置后三个月,和装载植入物后三个月(植入物放置后六个月)。
    结果:结果显示,椎弓下植入物的边缘骨丢失明显多于椎弓下植入物(p值=0.001),2mm及以下的软组织厚度组的边缘骨丢失明显多于2mm以上的软组织厚度组(p值<0.001)。植入物加载后三个月的边缘骨丢失量明显高于植入物放置后三个月(p值<0.001)。
    结论:种植体的垂直位置和种植体周围软组织的厚度是影响边缘骨丢失量的有效因素。在骨下植入物和软组织厚度较小的情况下,边缘骨丢失更多。时间因素显著影响边缘骨丢失量。
    背景:该临床试验已在伊朗临床试验注册中心注册,注册号IRCT20120215009014N415,注册日期20,220,110,(https//en.irct.ir/trial/60,991)。
    OBJECTIVE: One of the most important factors that has influence on dental implants success rate is marginal bone loss. The purpose of this study is to investigate the effect of the implant\'s vertical position and the soft tissue\'s thickness on the rate of marginal bone loss of the dental implant.
    METHODS: In this single-blind randomized clinical trial study, 56 implants placed in the posterior region of mandible of 33 patients (19 women, 14 men) were divided into two groups. The group of crestal (28 implants) and subcrestal (28 implants) implants, each group was divided into two sub-groups with soft tissue thickness of 2 mm and less than 2 mm (14 implants) and more than 2 mm (14 implants). The amount of marginal bone loss was measured by Scanora 5.2 program with radiographs Digital parallelism based on the effect of the vertical position of the implant, soft tissue thickness, three months after placement, and three months after loading implants (six months after implant placement).
    RESULTS: The results showed that marginal bone loss in subcrestal implants is significantly more than crestal implants (p-value = 0.001), and also marginal bone loss in the soft tissue thickness group of 2 mm and less is significantly more than the group of soft tissue thickness more than 2 mm (p-value < 0.001). The amount of marginal bone loss three months after implant loading was significantly higher than three months after implant placement (p-value < 0.001).
    CONCLUSIONS: The implant\'s vertical position and the soft tissue\'s thickness around the implant are effective factors in the amount of marginal bone loss. Marginal bone loss is more in subcrestal implants and in cases with less soft tissue thickness. The time factor significantly affects the amount of marginal bone loss.
    BACKGROUND: this clinical trial was registered at Iranian Registry of Clinical Trials, registration number IRCT20120215009014N415, registration date 20,220,110, (https//en.irct.ir/trial/60,991).
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  • 文章类型: Journal Article
    目的:研究未控制的2型糖尿病(T2DM)和血糖正常个体的4年临床结局和狭窄直径植入物周围的边缘骨质流失。
    方法:在11例糖化血红蛋白(HbA1C)浓度>6.5%的T2DM患者(试验组)和15例血糖正常患者(HbA1C<6.0%;对照组)中,一个窄直径的组织水平植入物,放置在后上颌骨或下颌骨,被调查。临床参数探测深度(PD),探查出血(BOP),附着损失(CAL),经济衰退,在24和48个月的功能后手动评估乳头出血指数(PBI)。从基线到术后48个月,分析了配对的数字根尖周X线片的边缘骨水平(MBL)变化。记录技术并发症。
    结果:在T2DM组中,11例患者可进行随访。48个月后植入物的总存活率为100%。在观察期,T2DM和血糖正常的患者之间的临床参数和MBL的平均值差异在统计学上无统计学意义。无技术并发症记录。
    结论:该研究表明,与非糖尿病患者相比,未控制的T2DM患者在48个月后接受ND植入物的临床结果令人鼓舞。
    结论:HbA1C>6.5%的患者可以从狭窄直径植入物的治疗中受益,避免复杂的手术干预和增强程序。登记号(临床试验。GOV):NCT04630691。
    OBJECTIVE: To investigate the four-year clinical outcome and marginal bone loss around narrow-diameter implants in patients with uncontrolled diabetes mellitus type 2 (T2DM) and normo-glycemic individuals.
    METHODS: In 11 T2DM patients with a concentration of glycated hemoglobin (HbA1C) > 6.5% (test group) and 15 normoglycemic patients (HbA1C < 6.0%; control group), one narrow-diameter tissue level implant, placed in the posterior maxilla or mandible, was investigated. The clinical parameters probing depth (PD), bleeding on probing (BOP), attachment loss (CAL), recession, and papilla bleeding index (PBI) were assessed manually after 24 and 48 months of function. The paired digital periapical radiographs were analyzed regarding the change in marginal bone level (MBL) from baseline to 48 months post-op. The technical complications were recorded.
    RESULTS: In the T2DM group, 11 patients were available for follow-ups. The overall implant survival rate after 48 months was 100%. The differences in means for the clinical parameters and the MBL between the T2DM and normo-glycemic patients for the observation period were statistically non-significant. No technical complications were recorded.
    CONCLUSIONS: The study demonstrated an encouraging clinical outcome with ND implants in patients with uncontrolled T2DM compared to non-diabetics after 48 months\' post loading.
    CONCLUSIONS: Patients with HbA1C > 6.5% may benefit from the treatment with narrow-diameter implants by avoiding complex surgical interventions with augmentation procedures. REGISTRATION NUMBER (CLINICALTRIALS.GOV): NCT04630691.
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  • 文章类型: Journal Article
    目的:评价白细胞介素-6(IL-6)抑制剂(tocilizumab)对兔骨整合过程中种植体周围细菌感染相关骨吸收的影响。
    方法:共有24名男性,包括9个月的新西兰白兔,拔除了他们的两颗下颌前牙。提取后三个月,24个一体式Dentium植入物(Ø2.5mm,骨内长度为12毫米)插入前下颌骨,将家兔分为4组(每组6只)。每组采用不同的治疗方法:空白对照组(BC);仅丝线结扎(阴性对照[NC]);丝线结扎并注射盐酸米诺环素软膏(阳性对照[PC]);丝线结扎并经耳廓静脉注射托珠单抗8mg/kg(实验[EP])。八周后,动物被处死,收集样本,然后使用显微计算机断层扫描(microCT)扫描进行分析,免疫组织化学分析,和组织学分析。
    结果:从microCT测量,EP组骨体积与总体积的比值(BV/TV)为67.00%±2.72%,高于其他三组(BC组的58.85%±2.43%,PC组55.72%±2.48%,NC组为36.52%±3.02%)。根据免疫组织化学分析,IL-6的表达在NC组高于BC组,PC,和EP组,但三组间无统计学差异。此外,EP组RANKL(核因子-κB受体活化因子配体)表达最低,其次是BC组,PC组,和NC组,表达最高;NC和PC组之间没有差异。组织学分析,在EP组的植入物表面发现了显著的新骨,在BC和PC组中可以看到稀疏和较少的新骨,骨吸收最严重的是NC组。
    结论:Tocilizumab,IL-6的抑制剂,在预防骨整合期间由细菌感染引起的植入物周围的骨丢失方面具有一定的作用。
    OBJECTIVE: To evaluate the effect of interleukin-6 (IL-6) inhibitor (tocilizumab) on bacterial infection-associated bone resorption around implants during osseointegration in rabbits.
    METHODS: At total of 24 male, 9-monthold New Zealand white rabbits were included, and their two mandibular anterior teeth were extracted. Three months after extraction, 24 one-piece Dentium implants (Ø 2.5 mm, intraosseous length of 12 mm) were inserted in the anterior mandible, and the rabbits were divided into four groups (n = 6 per group). Different treatment methods were used in each group: blank control group (BC); only silk ligation (negative control [NC]); silk ligation and injection with minocycline hydrochloride ointment (positive control [PC]); and silk ligation and injection with tocilizumab at 8 mg/kg via the auricle vein (experimental [EP]). Eight weeks later, the animals were sacrificed, and samples were collected and then analyzed using microcomputed tomography (microCT) scanning, immunohistochemical analysis, and histologic analysis.
    RESULTS: From the microCT measurement, the ratio of the bone volume to the total volume (BV/TV) in the EP group was 67.00% ± 2.72%, which was higher than that in the other three groups (58.85% ± 2.43% in the BC group, 55.72% ± 2.48% in the PC group, and 36.52% ± 3.02% in the NC group). From immunohistochemical analysis, the expression of IL-6 was found to be higher in the NC group than in the BC, PC, and EP groups, but there was no statistical difference between these three groups. Furthermore, the RANKL (receptor activator of nuclear factor-κB ligand) expression was the lowest in the EP group, followed by the BC group, the PC group, and the NC group, which had the highest expression; there was no difference between the NC and PC groups. Upon histologic analysis, significant new bone was found on the implant surfaces in the EP group, sparse and less new bone could be seen in the BC and PC groups, and the most serious bone resorption occurred in the NC group.
    CONCLUSIONS: Tocilizumab, an inhibitor of IL-6, has a certain effect in preventing bone loss around implants caused by bacterial infection during the osseointegration period.
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  • 文章类型: Journal Article
    目的:本研究的目的是比较组织形态学评估的新骨形成(NB),射线测量的移植物稳定性,以及用小(Bio-Oss-S,Geistlich)或大型(Bio-Oss-L,Geistlich)粒子。
    方法:使用裂口研究设计,对13例Bio-Oss-S颗粒(0.25~1mm)或Bio-Oss-L颗粒(1~2mm)患者进行了双侧上颌窦增大术.经过6个月的愈合期,在磨牙区域进行轴向骨活检,用于NB的组织学/组织形态计量学分析,包括随后分阶段的植入物放置。为了确定移植物的稳定性,上颌窦增强垂直移植物高度在鼻窦增强后立即进行影像学测量,在植入物放置时,以及扩增后2年和4年的随访。此外,在负重后1年和3年评估临床种植-修复结果(生存率/成功率/边缘骨丢失).
    结果:11例患者的22个鼻窦进行口裂评估,最终可用于数据和统计分析。轴向获取的骨活检的组织形态计量学分析显示存在NB(S:25.5%±7.0%vsL:23.6%±11.9%;P=.640),残余移植物颗粒(S:19.6%±9.2%vsL:17.5%±6.3%;P=.365)以及结缔组织(S:54.9%±9.2%vsL:58.9%±12.5%;P=.283),在使用小颗粒(Bio-Oss-S)和大颗粒(Bio-Oss-L)之间没有显著差异。然而,与大颗粒移植部位(19.9%±12.9%)相比,小颗粒移植部位(27.9%±14.8%)的骨与移植物接触(BGC)明显更高(P=.021),代表了显著更高的骨传导性。两种粒径均显示出随时间(4年)约10%的显著(P<.01)垂直接枝高度降低,与植入物放置后的任何随访期相比,在鼻窦增大和植入物放置之间的时间段内移植物减少。在3年的植入后评估中,所有植入物和假体存活(100%),种植体周围边缘骨丢失(S:0.52±0.19mm;L:0.48±0.15mm)以及种植体周围健康状况(S:87.5%,L:81.2%)在使用两种不同的异种移植颗粒插入的植入物之间没有差异。
    结论:使用小型和大型牛异种移植颗粒进行上颌窦增强提供了可比的骨形成,确保稳定的移植物尺寸与高植入成功率和健康的种植体周围条件相结合。然而,小粒径导致较高的BGC,提供比大粒径更高的骨传导性。
    The aim of the present study was to compare the histomorphometrically evaluated new bone formation (NB), the radiographically measured graft stability, and the clinical implant outcome for maxillary sinus augmentation grafted with deproteinized bovine bone mineral (DBBM) with either small (Bio-Oss-S, Geistlich) or large (Bio-Oss-L, Geistlich) particles.
    Using a split-mouth study design, bilateral maxillary sinus augmentation was performed in 13 patients either with Bio-Oss-S particles (0.25 to 1 mm) or Bio-Oss-L particles (1 to 2 mm). After a healing period of 6 months, bone biopsies were axially retrieved in the molar region for histologic/histomorphometric analysis of NB, including subsequent staged implant placement. To determine graft stability, the maxillary sinus augmentation vertical graft heights were radiographically measured immediately after sinus augmentation, at implant placement, and at the 2- and 4-year post-augmentation follow-ups. In addition, the clinical implant-prosthodontic outcome (survival/ success/marginal bone loss) was assessed at 1 and 3 years post-loading.
    A total of 22 sinuses from 11 patients with split-mouth evaluation were ultimately available for data and statistical analysis. Histomorphometric analysis of the axially retrieved bone biopsies revealed the presence of NB (S: 25.5% ± 7.0% vs L: 23.6% ± 11.9%; P = .640), residual graft particles (S: 19.6% ± 9.2% vs L: 17.5% ± 6.3%; P = .365) as well as connective tissue (S: 54.9% ± 9.2% vs L: 58.9% ± 12.5%; P = .283), without significant differences between the use of small (Bio-Oss-S) and large (Bio-Oss-L) particles. However, there was significantly (P = .021) higher bone-to-graft contact (BGC) for the small-particle graft sites (27.9% ± 14.8%) compared to the large-particle graft sites (19.9% ± 12.9%), representing a significantly higher osteoconductivity. Both particle sizes showed significant (P < .01) vertical graft height reduction over time (4 years) of about 10%, with predominant graft reduction in the time period between sinus augmentation and implant placement compared to any follow-up periods after implant placement. At the 3-year post-loading implant evaluation, all implants and prostheses survived (100%), and the peri-implant marginal bone loss (S: 0.52 ± 0.19 mm; L: 0.48 ± 0.15 mm) as well as the peri-implant health conditions (S: 87.5%, L:81.2%) did not differ between implants inserted with the two different xenograft particles used.
    The use of small and large bovine xenograft particles for maxillary sinus augmentation provides for comparable bone formation, ensuring stable graft dimensions combined with high implant success and healthy peri-implant conditions. However, small particle size resulted in a higher BGC, providing for higher osteoconductivity than with the larger particle size.
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  • 文章类型: Journal Article
    目的:通过评估髂骨的厚度和弯曲度,了解髂骨的形态特征,为髂骨瓣重建颌骨提供建议和帮助。
    方法:本研究纳入了在2020年至2022年之间在手术前进行腹部区域螺旋CT检查的100例患者。创建髂骨的3D重建图像。沿着髂棘的中心线(VP2~VP10)每2cm制作5个垂直于髂棘的垂直平面。在这些垂直平面上,沿髂骨的长轴(D1~D4)每1cm做4条垂直线。这些地点的厚度,测量髂骨的水平角(HA)以及拐点与前上棘中心点(DIA)之间的距离。
    结果:在VP6〜VP10的D1〜D4和D3和D4的VP2〜VP10的水平上,髂骨厚度显着降低(P<0.05)。髂峰HA为149.13±6.92°,DIA为7.36±1.01cm。髂骨厚度,HA和DIA与患者年龄的相关性非常弱或弱,身高和体重。
    结论:髂棘平均厚度从前到后大致减少,从上到下。髂棘的厚度和曲率很难按年龄预测,身高和体重。
    结论:在颌骨重建手术前建议采用虚拟手术计划,而髂棘突走向肺泡突可能是更好的选择。
    OBJECTIVE: to understand the morphological characteristics of iliac crest and provide advice and assistance for jaw bone reconstruction with iliac bone flap by evaluating the thickness and curvature of iliac crest.
    METHODS: 100 patients who had taken Spiral CT of the Abdominal region before surgeries between 2020 and 2022 were included in this study. 3D reconstruction images of the iliac bones were created. 5 vertical planes perpendicular to the iliac crest were made every 2 cm along the centerline of the iliac crest (VP2 ~ VP10). On these vertical planes, 4 perpendicular lines were made every 1 cm along the long axis of the iliac crest (D1 ~ D4). The thicknesses at these sites, horizontal angle (HA) of iliac crest and the distance between inflection point and the central point of anterior superior iliac spine (DIA) were measured.
    RESULTS: The thickness of iliac bone decreased significantly from D1 ~ D4 on VP6 ~ VP10 and from VP2 ~ VP10 on D3 and D4 level (P<0.05). HA of iliac crests was 149.13 ± 6.92°, and DIA was 7.36 ± 1.01 cm. Iliac bone thickness, HA and DIA had very weak or weak correlation with patient\'s age, height and weight.
    CONCLUSIONS: The average thicknesses of iliac crest were decreased approximately from front to back, from top to bottom. The thickness and curvature of the iliac crest were difficult to predict by age, height and weight.
    CONCLUSIONS: Virtual surgical planning is recommended before jaw bone reconstruction surgery with iliac bone flap, and iliac crest process towards alveolar process might be a better choice.
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  • 文章类型: Journal Article
    目的:机器人越来越多地用于各种专业的外科手术。然而,缺乏有关机器人辅助牙种植手术准确性的信息。这项初步临床研究旨在研究自主种植机器人(ADIR)系统在部分缺牙病例中的准确性。
    方法:使用ADIR系统在13名参与者中放置了总共20个植入物。评估植入物与计划位置的偏差以确定准确性。条目,顶点,和角度偏差被描述为平均值±标准偏差。双样本t检验用于比较皮瓣组和无舌组之间以及上颌和下颌植入物之间的植入物偏差(α=0.05)。
    结果:条目,顶点,角度偏差为0.65±0.32mm,0.66±0.34mm,和1.52±1.01°,分别,皮瓣和无瓣入路之间无统计学差异(P>.05)。任何参与者均未遇到不良事件。
    结论:本临床系列的DIR准确性与静态和动态计算机辅助植入手术的报告相当。机器人计算机辅助植入手术可能对牙科植入物的放置有用,有可能提高程序的质量和安全性。
    结论:这项研究的结果表明,ADIR系统可用于牙科种植手术。
    OBJECTIVE: Robots are increasingly being used for surgical procedures in various specialties. However, information about the accuracy of robot-assisted dental implant surgery is lacking. This pilot clinical study aimed to investigate the accuracy of an autonomous dental implant robotic (ADIR) system in partially edentulous cases.
    METHODS: The ADIR system was used to place a total of 20 implants in 13 participants. Implant deviation from the planned positions was assessed to determine accuracy. The entry, apex, and angular deviations were described as means ± standard deviation. A two-sample t test was used to compare implant deviation between the flap and flapless groups and between maxillary and mandibular implants (α = .05).
    RESULTS: The entry, apex, and angular deviations were 0.65 ± 0.32 mm, 0.66 ± 0.34 mm, and 1.52 ± 1.01°, respectively, with no statistically significant difference between the flap and flapless approaches (P > .05). No adverse events were encountered in any of the participants.
    CONCLUSIONS: DIR accuracy in this clinical series was comparable to that reported for static and dynamic computer-assisted implant surgery. Robotic computer-assisted implant surgery may be useful for dental implant placement, potentially improving the quality and safety of the procedure.
    CONCLUSIONS: The findings of this study showed that the ADIR system could be useful for dental implant surgery.
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  • 文章类型: Journal Article
    背景:这项研究评估了在水平缺陷的上颌骨中添加NanoBone®并同时植入富含血小板的纤维蛋白膜覆盖在水平缺陷的上颌骨的临床益处和患者发病率。
    方法:将40例上颌骨劈开并同时植入的患者随机分为研究组:对照组(富血小板纤维蛋白膜)和实验组(富血小板纤维蛋白膜+Nanobone®)。锥形束计算机断层扫描融合技术用于评估外科手术五个月后的颌骨和水平骨变化。术后一周记录患者发病率。
    结果:术后5个月,对照组颊骨吸收为1.26±0.58mm,实验组为1.14±0.63mm。对照组舌骨骨吸收为1.40±0.66mm,实验组为1.47±0.68mm。对照组的水平骨宽度增加为1.46±0.44mm,实验组为1.29±0.73mm。研究组之间在蠕动和水平骨变化以及患者发病率方面没有显着统计学差异。
    结论:在本研究中添加NanoBone®的断层摄影评估结果,研究组之间在蠕动和水平骨变化以及患者发病率方面没有统计学上的显着差异。应进行更多关于间隙填充的随机对照临床试验,比较不同的植骨材料与未植骨材料。
    结果:
    NCT02836678,2017年1月13日。
    BACKGROUND: This study evaluated the clinical benefits of adding NanoBone® with split-crest technique and simultaneous implant placement covered with platelet-rich fibrin membrane in horizontally deficient maxillary ridges in terms of crestal and horizontal bone changes and patient morbidity.
    METHODS: Forty patients indicated for maxillary ridge splitting and simultaneous implant placement were assigned randomly to the study groups: control group (Platelet Rich Fibrin membrane) and test group (Platelet Rich Fibrin membrane + Nanobone®). The Cone Beam Computed Tomography Fusion technique was utilized to assess crestal and horizontal bone changes after five months of the surgical procedure. Patient morbidity was recorded for one week post-surgical.
    RESULTS: Five months post-surgical, buccal crestal bone resorption was 1.26 ± 0.58 mm for the control group and 1.14 ± 0.63 mm for the test group. Lingual crestal bone resorption was 1.40 ± 0.66 mm for the control group and 1.47 ± 0.68 mm for the test group. Horizontal bone width gain was 1.46 ± 0.44 mm for the control group and 1.29 ± 0.73 mm for the test group. There was no significant statistical difference between study groups regarding crestal and horizontal bone changes and patient morbidity.
    CONCLUSIONS: The tomographic assessment of NanoBone® addition in this study resulted in no statistically significant difference between study groups regarding crestal and horizontal bone changes and patient morbidity. More randomized controlled clinical trials on gap fill comparing different bone grafting materials versus no grafting should be conducted.
    RESULTS:
    UNASSIGNED: NCT02836678, 13th January 2017.
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  • 文章类型: Journal Article
    目的:设计生物活性表面以增加表面与细胞之间的相互作用。这可以加速生物稳定性和装载方案。
    方法:纳入36例D3-D4骨密度患者,分为两组。放置30个生物活性物质(测试组)和30个传统(对照组)表面植入物。插入扭矩值(Ncm),插入扭矩曲线积分(累积扭矩,Ncm),扭矩密度(Ncm/sec),在三个时间点测量的植入物稳定性商(ISQ)(基线(T0),手术后30(T30)和45(T45)天),评估负荷6个月时的边缘骨丢失(MBL)。
    结果:试验组T0、T30、T45的ISQ平均值和标准差分别为74.57±7.85、74.78±7.31、74.97±6.34,对照组为77.12±5.83、73.33±6.13、73.44±7.89,分别。数据分析显示,在T0-T30(p=0.005)和T30-T45(p=0.012)的ΔISQ之间存在显着差异。与基线相比,对照组在T30(p=0.01)和T45(p=0.03)时ISQ显着降低,试验组无明显变化。由于ISQ值≥70的稳定性,在45天后对26个测试组和23个对照组的植入物进行了功能性加载。相反,由于在T45时的ISQ<70,在90天后加载了四个测试组植入物和一个对照组植入物,180天后加载6个对照组植入物。基线时的插入扭矩和ISQ均与骨密度(以Hounsfield为单位)无关。基线时累积扭矩和ISQ之间没有显著相关性。基线时扭矩密度和ISQ之间的相关性存在显著的正斜率,D3比D4更突出。在第30天和第45天,D3骨中的测试组的这种相关性仍然显着(在两个时间范围内,p<0.01)。但不是在D4骨,在CG中并不显著。
    结论:在骨愈合的早期阶段,生物活性表面在D3-D4骨质量的植入物稳定性方面表现出更好的行为。临床相关性这项研究表明,使用生物活性表面改善了从初级到次级稳定性的转变,特别是在骨骼环境较差的情况下(D3/D4骨骼)。
    OBJECTIVE: Bioactive surfaces were designed to increase the interaction between the surface and the cells. This may speed up the biological stability and loading protocols.
    METHODS: 36 patients with D3-D4 bone density were recruited and allocated into two groups. 30 bioactive (test group) and 30 traditional (control group) surfaced implants were placed. Insertion torque value (Ncm), insertion torque curve integral (cumulative torque, Ncm), torque density (Ncm/sec), implant stability quotient (ISQ) measured at three timepoints (baseline (T0), 30 (T30) and 45 (T45) days after surgery), and marginal bone loss (MBL) at 6 months of loading were assessed.
    RESULTS: The mean ISQ and standard deviation at T0, T30, T45 were respectively 74.57 ± 7.85, 74.78 ± 7.31, 74.97 ± 6.34 in test group, and 77.12 ± 5.83, 73.33 ± 6.13, 73.44 ± 7.89 in control group, respectively. Data analysis showed significant differences between groups in ΔISQ at T0-T30 (p = 0.005) and T30-T45 (p = 0.012). Control group showed a significant decrease in ISQ at T30 (p = 0.01) and T45 (p = 0.03) compared to baseline, while no significant change was observed in test group. Due to the stability of the ISQ value ≥ 70, 26 test group and 23 control group implants were functionally loaded after 45 days. Conversely, due to the ISQ < 70 at T45, four test group implants and one control group implant were loaded after 90 days, and 6 control group implants were loaded after 180 days. Neither insertion torque nor ISQ at baseline were correlated with bone density (in Hounsfield units). There was no significant correlation between cumulative torque and ISQ at baseline. There was a significant positive slope in the correlation between torque density and ISQ at baseline, more accentuated in D3 than D4. This correlation remained significant for the test group in D3 bone at day 30 and 45 (p < 0.01 in both time frames), but not in D4 bone, and it was not significant in CG.
    CONCLUSIONS: The bioactive surface showed better behavior in terms of implant stability in D3-D4 bone quality in the early stages of bone healing. Clinical relevance This study demonstrated that the transition from primary to secondary stability is improved using bioactive surface, especially in cases of poor bone environment (D3/D4 bone).
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